Salvage Treatment With Lenalidomide and Dexamethaosne (LEN-DEX) in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL)

NCT ID: NCT00786851

Last Updated: 2016-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-08-31

Brief Summary

This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of Lenalidomide (Len) and Dexamethasone (Dex) in patients with relapsed/refractory mantle cell lymphoma (MCL).

Conditions

MANTLE CELL LYMPHOMA

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Lenalidomide will be supplied as 5 mg and 25 mg capsules for oral administration.Dexamethasone (Soldesam 0.2%) will be supplied as 20 mg liquid for oral administration (1 bottle = 20 mg; daily dose = 2 bottles = 40 mg).

Group Type: EXPERIMENTAL

Lenalidomide and Dexametasone

Intervention Type: DRUG

Lenalidomide will be supplied as 5 mg and 25 mg capsules for oral administration.Dexamethasone (Soldesam 0.2%) will be supplied as 20 mg liquid for oral administration (1 bottle = 20 mg; daily dose = 2 bottles = 40 mg).

Interventions

Lenalidomide and Dexametasone

Lenalidomide will be supplied as 5 mg and 25 mg capsules for oral administration.Dexamethasone (Soldesam 0.2%) will be supplied as 20 mg liquid for oral administration (1 bottle = 20 mg; daily dose = 2 bottles = 40 mg).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of MCL
• Understand and voluntarily sign an informed consent form;
• Able to adhere to the study visit schedule and other protocol requirements;
• Age ≥ 18;
• Patients treated with at least one prior treatment regimen, not eligible for or relapsed after more intensive treatments (stem cell transplant);
• Patients with refractory or relapsed disease;
• Measurable and/or valuable disease;
• Adequate haematological counts: ANC > 1.5 x 109/L and platelet count > 75 x 109/L unless due to bone marrow involvement by MCL;
• Conjugated bilirubin up to 2 x ULN unless due to liver involvement by MCL;
• Alkaline phosphatase and transaminases up to 2 x ULN unless due to liver involvement by MCL;
• Creatinine clearance ≥ 50 ml/min;
• HIV negativity;
• HCV negativity;
• HBV negativity or patients with HBcAb +, HbsAg -, HBs Ab+/- and anti HBV prophylaxis with lamivudine;
• Non peripheral neuropathy or CNS disease;
• Life expectancy > 6 months;
• Performance status < 2 according to ECOG scale;Disease free of prior malignancies (a part MCL) with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast;
• Written informed consent;
• Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed;

Exclusion Criteria

• Patients who have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study;
• CNS disease (meningeal and/or brain involvement by lymphoma);
• TVP in the last year;
• History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances;
• Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug);
• Creatinine clearances < 50 ml/min;
• HIV positivity;
• HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- in anti HBV prophilaxis with lamivudine;
• Pregnant or lactating women;
• Hypersensitivity reactions to previous thalidomide (if any);
• Prior rash ≥ 3 while taking thalidomide (if any);
• Active opportunistic infection;
• Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

OTHER

Sponsor Role: collaborator

Fondazione Italiana Linfomi - ETS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesco Zaja, MD

Role: STUDY_DIRECTOR

Ospedale S. Maria della Misericordia, Udine

Locations

Ospedale SS. Antonio Biagio e Cesare Arrigo

Alessandria, , Italy

Centro diriferimento oncologico

Aviano (PN), , Italy

Ematologia Spedali Civili

Brescia, , Italy

Ematologia Ospedale Businco

Cagliari, , Italy

Fondazione IRCCS UO Ematologia 1

Milan, , Italy

Ospedale Niguarda Cà granda

Milan, , Italy

Ospedale San Raffaele Ematologia

Milan, , Italy

Università Policlinico San Matteo Divione di Ematologia

Pavia, , Italy

AO Bianchi Melacrino Morelli UO Ematologia

Reggio Calabria, , Italy

AO Arcispedale S.Maria Nuova Ematologia

Reggio Emilia, , Italy

Università La Sapienza Ematologia

Roma, , Italy

Istituto Clinica Humanitas

Rozzano (MI), , Italy

AO Universitaria di Sassari Istituto di Ematologia

Sassari, , Italy

Policlinico Le Scotte Clinica Ematologica

Siena, , Italy

Osp. San Giovanni Battista Ematologia2

Torino, , Italy

Osp. Cardinalle Panico Divisione di Ematologia

Tricase (LE), , Italy

AO Universitaria clinica Ematologica ed Unità terapie Cellulari Carlo Melzi

Udine, , Italy

Countries

Italy

References

Zaja F, De Luca S, Vitolo U, Orsucci L, Levis A, Salvi F, Rusconi C, Ravelli E, Tucci A, Bottelli C, Balzarotti M, Brusamolino E, Bonfichi M, Pileri SA, Sabattini E, Volpetti S, Monagheddu C, Vacca A, Ria R, Fanin R. Salvage treatment with lenalidomide and dexamethasone in relapsed/refractory mantle cell lymphoma: clinical results and effects on microenvironment and neo-angiogenic biomarkers. Haematologica. 2012 Mar;97(3):416-22. doi: 10.3324/haematol.2011.051813. Epub 2011 Nov 4.

Reference Type: DERIVED

PMID: 22058200 (View on PubMed)

Other Identifiers

EudraCT Number 2008-000044-14

Identifier Type: -

Identifier Source: secondary_id

IIL LEN-DEX MCL 07

Identifier Type: -

Identifier Source: org_study_id